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[大学生论坛]:使用心电设备的患者进行核磁共振检查的安全性研究

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袁梅清 发表于 2017-12-30 21:53:50 | 显示全部楼层 |阅读模式

Safetyof Magnetic Resonance Imaging in Patients with Cardiac Devices

使用心电设备的患者进行核磁共振检查的安全性研究


Background

Patientswho have pacemakers or defibrillators are often denied the opportunity toundergo magnetic resonance imaging (MRI) because of safety concerns, unless thedevices meet certain criteria specified by the Food and Drug Administration(termed “MRI-conditional” devices).

背景

出于安全顾虑,使用心脏起搏器或者心脏除颤器的患者经常会拒绝进行核磁共振检查。除非这些设备达到美国食品药物管理局的特定标准(称之为“有条件的MRI”设备)。


Methods

Weperformed a prospective, nonrandomized study to assess the safety of MRI at amagnetic field strength of 1.5 Tesla in 1509 patients who had a pacemaker (58%)or an implantable cardioverter–defibrillator (42%) that was not considered tobe MRI-conditional (termed a “legacy” device). Overall, the patients underwent2103 thoracic and nonthoracic MRI examinations that were deemed to beclinically necessary. The pacing mode was changed to asynchronous mode 异步模式forpacing-dependent patients and to demand mode for other patients.Tachyarrhythmia functions were disabled. Outcome assessments included adverseevents and changes in the variables that indicate lead and generator functionand interaction with surrounding tissue (device parameters).

方法

我们采用前瞻性非随机研究,评价1509位使用心脏起搏器(58%)或者埋藏式心脏复律除颤器(42%)的患者在磁场强度为1.5泰斯拉下进行MRI的安全性,这些设备均不是“有条件的MRI”设备(称之为“遗留设备”)。总的来说,这些患者进行2103胸部或非胸部的MRI检查是在临床上被认为是有必要的。对那些依赖起搏器的患者,起搏模式改为异位模式,对其他患者则采用需求模式。快速性心律失常没有发生。结果评估包括不良反应,以及反应铅的变量的变化和发生器的功能以及其与周围组织的相互作用(设备参数)。


Results

Nolong-term clinically significant adverse events were reported. In nine MRIexaminations (0.4%; 95% confidence interval, 0.2 to 0.7), the patient’s devicereset to a backup mode. The reset was transient in eight of the nineexaminations. In one case, a pacemaker with less than 1 month left of batterylife reset to ventricular inhibited pacing and could not be reprogrammed; thedevice was subsequently replaced. The most common notable change in deviceparameters (>50% change from baseline) immediately after MRI was a decreasein P-wave amplitude, which occurred in 1% of the patients. At long-termfollow-up (results of which were available for 63% of the patients), the mostcommon notable changes from baseline were decreases in P-wave amplitude (in 4%of the patients), increases in atrial capture threshold (4%), increases inright ventricular capture threshold (4%), and increases in left ventricularcapture threshold (3%). The observed changes in lead parameters were notclinically significant and did not require device revision or reprogramming.

结果

没有发生显著的长期临床不良反应。在9个MRI检查中(0.4%;95%置信区间为0.2-0.7),患者的设备重置为备份模式。在9个MRI检查中,8个出现短暂的重置。其中有一例,起搏器的电池还剩不到一个月的寿命,重置为心室抑制型起搏,但是却不能再调整,相应的起搏器也替换掉了。做过MRI检查之后,设备参数(>50%基准线)最显著的变化是1%的患者出现了P波振幅的减小。在长期的随访中(其结果对63%的患者是有用的),最显著的变化是4%的患者P波振幅减小,4%出现心房捕获阈值增加,4%右心室捕获阈值增加,3%左心室捕获阈值增加。主要参数的显著变化在临床上却不是特别重要,也不需要对设备进行修改或者重新编程。


Conclusions

Weevaluated the safety of MRI, performed with the use of a prespecified safetyprotocol, in 1509 patients who had a legacy pacemaker or a legacy implantablecardioverter–defibrillator system. No long-term clinically significant adverseevents were reported.

结论

预规定的安全协议书的指导下,对1509位使用旧起搏器或者旧埋藏式心脏复律除颤器的患者进行MRI安全性的评价。没有出现临床上长期严重的不良反应的报告。


作者:Saman Nazarian

期刊名称:The New England Journal of Medicine

发表时间:2017-12-28

N Engl J Med 2017; 377:2555-2564December28, 2017DOI:10.1056/NEJMoa1604267


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